RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with docetaxel and gemcitabine hydrochloride may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel and gemcitabine hydrochloride works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

PFS is defined as time to death or first occurrence of documented disease progression assessed by the investigator as per the RECIST guidelines (at lease a 20% increase in the diameter of a lesion, in addition to an absolute increase of 5mm). If no deaths occur prior to progression, this measure will be the same as the median time to progression.

Secondary Outcome Measures:

Median Time to Progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Time to progression (TTP) is defined as the time from start of treatment to first evidence of disease progression, defined per the RECIST 1.1 criteria as at least a 20% increase in the diameter of a lesion and an absolute increase of at least 5mm.

Best Response [ Time Frame: 1 year ] [ Designated as safety issue: No ]

The number of patients with a response will be assessed using the RECIST criteria of complete response (the disappearance of all target lesions); partial response (at least a 30% decrease in the diameter of lesions); progressive disease at least a 20% increase in the diameter of lesions); or stable disease(neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease)

Evaluate the median time to progression in patients treated with this regimen.

Estimate the response rate in patients treated with this regimen.

Determine the median overall survival of patients treated with this regimen.

Determine the incidence of adverse events associated with this regimen in these patients.

OUTLINE: Patients receive bevacizumab IV over 30-90 minutes and docetaxel IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease may then continue to receive bevacizumab alone for up to 12 months in the absence of disease progression.

After completion of study treatment, patients are followed up every 3 months.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed non-squamous cell non-small cell lung cancer

Stage IIIB (with pleural effusion), stage IV, or recurrent disease

Bidimensionally measurable disease

No known CNS disease, except for previously treated brain metastasis defined as no evidence of progression or hemorrhage after treatment AND no ongoing requirement for dexamethasone as documented by clinical examination, MRI, or CT scan

Treatment for brain metastases may have included whole brain radiotherapy, radiosurgery (gamma knife, LINAC, or equivalent), or a combination of therapy as deemed appropriate by the treating physician

Stable dose of anticonvulsants allowed

No known metastatic disease to the gastrointestinal tract (e.g., stomach, small bowel, or large bowel)

PATIENT CHARACTERISTICS:

ECOG performance status 0-1

Life expectancy > 3 months

ANC ≥ 1,500/mm^3

Platelet count ≥ 100,000/mm^3

Hemoglobin ≥ 9 g/dL

Bilirubin ≤ 2.0 mg/dL

AST or ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5.0 times ULN if hepatic metastases are present)

No evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)

No history of colonic diverticular disease (i.e., diverticulosis or diverticulitis)

No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months

No serious, nonhealing wound, ulcer, or bone fracture

No known hypersensitivity to any component of bevacizumab

No hemoptysis (bright red blood of ≥ ½ teaspoon per episode) within the past 3 months

No significant traumatic injury within the past 28 days

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

No prior chemotherapy or biological therapy

No prior radiotherapy to an area of measurable disease unless there is documented progressive disease after completion of therapy

More than 2 weeks since prior radiotherapy

More than 4 weeks since prior and no concurrent participation in another experimental drug study, except for a Genentech-sponsored bevacizumab cancer study

More than 28 days since prior major surgical procedure or open biopsy

More than 3 months since prior abdominal surgery

More than 3 months since prior neurosurgical resection or brain biopsy

More than 7 days since prior core biopsy or other minor surgical procedure, except placement of a vascular access device

No concurrent major surgical procedure

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970684